How does this medication work? What will it do for me?

Mirtazapine belongs to the group of medications known as tetracyclic antidepressants. Antidepressants are used to help relieve the symptoms of depression such as feeling low, sleeping problems, loss of appetite, and loss of interest in activities that you would normally enjoy doing.

When you have depression, certain chemicals in the brain are out of their normal balance. Antidepressants such as mirtazapine work by helping to bring the chemicals back into balance. Antidepressants usually take at least a few weeks to achieve their beneficial effect, so it is important to have patience and take the medication exactly as prescribed by your doctor.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

15 mg
Each yellow, oval, film-coated tablet, debossed with "1" on the left side of a score line and "5" on the right side, with "MIR" on the other side of the tablet, contains mirtazapine 15 mg. Nonmedicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide, and titanium dioxide.

30 mg
Each red-brown, oval, film-coated tablet, debossed with "3" on the left side of a score line and "0" on the ridge side, with "MIR" on the other side of the tablet, contains mirtazapine 30 mg. Nonmedicinal ingredients: colloidal silicon dioxide, iron oxide yellow, iron oxide red, lactose monohydrate, macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part.hydrolyzed, sodium starch glycolate, talc, and titanium dioxide.

How should I use this medication?

The recommended starting dose of mirtazapine for adults is 15 mg taken once daily in the evening before going to bed. The doctor may increase the dose to 30 mg after 1 to 2 weeks, depending on circumstances. The maximum recommended dose of mirtazapine is 45 mg daily. Swallow the tablets whole with water. Do not chew the tablets.

If you are taking the orally disintegrating tablet form of mirtazapine, it is important to handle these tablets properly.

The orally-disintegrating tablets have been designed to rapidly dissolve on the tongue and can be swallowed with saliva. Ensure that your hands are dry when you remove the tablet from its blister packaging, and then immediately place the tablet on your tongue. Note that tablets must be used immediately after removal from packaging. The tablets cannot be stored once they are removed from their packaging.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is normal to not feel any difference for the first 2 to 4 weeks of taking this medication. If you have side effects from this medication, talk with your doctor or pharmacist before stopping it.

It is important to take this medication exactly as prescribed by your doctor. If you miss your evening dose, do not take the missed dose the next morning. Skip the missed dose and continue with your regular dosing schedule in the evening. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take mirtazapine if you:

are allergic to mirtazapine or any ingredients of the medication

have taken any MAO inhibitors (e.g., phenelzine, tranylcypromine) in the previous 2 weeks

signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

swelling of the hands or feet with shortness of breath

thoughts of suicide or hurting yourself

tremors

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

HEALTH CANADA ADVISORY

March 28, 2014

Health Canada has issued new restrictions concerning the use of Remeron and Remeron RD (mirtazapine). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abnormal heart rhythms: Mirtazapine may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heart beat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Blood disorders: Mirtazapine can affect the production of blood cells in your body. It may cause a reduced number of white blood cells to be available to fight infection. If you notice any signs of infection, such as fever, chills, sore throat or flu-like symptoms, contact your doctor as soon as possible.

Diabetes: Mirtazapine may cause a loss of control of diabetes by increasing blood glucose (sugar). If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Mirtazapine may cause drowsiness. People taking mirtazapine should avoid operating hazardous machinery (including cars) until they are certain that the medication does not impair their mental alertness, judgment, or physical coordination.

Medical conditions: Mirtazapine may worsen a number of medical conditions. If you have glaucoma, low blood pressure (especially low blood pressure upon standing up [orthostatic hypotension]), prostate problems, or urinary retention, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If symptoms of any of these conditions worsen, contact your doctor as soon as possible.

Kidney disease: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Liver disease: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Neuroleptic malignant syndrome (NMS): Mirtazapine, like other medications that affect serotonin, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Seizures: If you have a seizure disorder or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin Syndrome: Severe reactions are possible when mirtazapine is combined with other medications that act on serotonin, such as antipsychotics, "triptan" migraine medications and other medications used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking any of these groups of medications, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may cause side effects such as dizziness, agitation, confusion, headache, sweating and others. A gradual reduction in dose over a period of time is recommended. If you are thinking of stopping the medication, check with your doctor first.

Suicidal or agitated behaviour: Adults and children taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking this medication.

Mirtazapine may cause symptoms of mania to worsen or to return. People with a history of manic symptoms or bipolar disorder should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. It has been reported that babies born to women who have taken mirtazapine during the last trimester of pregnancy may experience complications that result in an increase in the length of their hospital stay. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if mirtazapine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of this medication have not been established for children and adolescents under 18 years of age. There have been reports that the use of this medication by children and adolescents younger than 18 years may cause behavioural and emotional changes, such as suicidal thoughts and behaviour. Children and adolescents who take this medication should be closely monitored and encouraged to report all changes in feelings to their doctor and caregiver.

Seniors: Seniors often have decreased kidney or liver function. For this reason, they often have this medication build up in the body and experience more side effects than younger people. A lower dose may be needed for older people.

What other drugs could interact with this medication?

There may be an interaction between mirtazapine and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.